EP1983933B1 - Endoluminalprothese mit seitenarm - Google Patents

Endoluminalprothese mit seitenarm Download PDF

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Publication number
EP1983933B1
EP1983933B1 EP07750717A EP07750717A EP1983933B1 EP 1983933 B1 EP1983933 B1 EP 1983933B1 EP 07750717 A EP07750717 A EP 07750717A EP 07750717 A EP07750717 A EP 07750717A EP 1983933 B1 EP1983933 B1 EP 1983933B1
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EP
European Patent Office
Prior art keywords
side branch
stent graft
ring
tubular
stent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP07750717A
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English (en)
French (fr)
Other versions
EP1983933A2 (de
Inventor
David Ernest Hartley
Susan Morriss
Timothy A Chuter
Werner D. Ducke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
William A Cook Australia Pty Ltd
Cook Medical Technologies LLC
Original Assignee
William A Cook Australia Pty Ltd
Cook Medical Technologies LLC
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Application filed by William A Cook Australia Pty Ltd, Cook Medical Technologies LLC filed Critical William A Cook Australia Pty Ltd
Publication of EP1983933A2 publication Critical patent/EP1983933A2/de
Application granted granted Critical
Publication of EP1983933B1 publication Critical patent/EP1983933B1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30327—The prosthesis having different structural features at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • This invention relates to a medical device and more particularly to a stent graft for endovascular deployment.
  • Stent grafts have been devised for endovascular deployment to bypass a diseased portion of a vessel and such stent grafts can be deployed into body vessels such as the aorta. Where there are branches from the body vessel such as the coeliac artery, the superior mesenteric artery and the renal arteries it is desirable to have a fenestration in the stent graft so that an extension arm can be placed through the fenestration to allow flow into the branch vessel.
  • stent graft with fenestrations in the wall of the stent graft provides difficulty for catheterisation and sealing and there have been proposed stent grafts with internal branches into which can be deployed a side arm extension to extend from the internal branch of the stent graft into a branch vessel and so that the side arm extension can seal with in the internal branch.
  • stent graft having a tubular body of graft material, a number of self expanding stents associated with the tubular body to define a fluid flow path through the stent graft when the self expanding stents are in their expanded configurations.
  • At least one fenestration in the tubular body is adapted to receive a side arm stent graft to provide a fluid flow path from the tubular body and through the side arm stent graft.
  • the or each fenestration has at least an inner ring and an outer ring and graft material extending from the inner ring to the outer ring and the outer ring being in the tubular body of graft material.
  • the inner ring can be hinged to the outer ring or concentric within the outer ring.
  • An intermediate ring may also be used between the inner and outer rings.
  • the invention will be particularly discussed in relation to deployment of a stent graft into the renal and suprarenal regions of the aorta for deployment of a stent graft into coeliac artery, the superior mesenteric artery and the renal arteries, however, the invention is not so limited and may be applied to other regions where there are branches from a main graft such as in the thoracic arch.
  • distal when used with respect to a portion of the aorta, a deployment device or a prosthesis, means the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart.
  • proximal when applied to other vessels similar terms such as caudal and cranial should be understood.
  • a stent graft comprising a tubular body of a biocompatible material, at least one fenestration in the tubular body and a tubular side branch sealingly received in the at least one fenestration such a that an inner portion of the tubular side branch extends within the tubular body and an outer portion of the tubular side branch extends exteriorly of the tubular body said inner portion of said tubular side branch comprising a resilient ring therearound, said resilient ring including a linear portion for engagement against an inner wall of the tubular body.
  • tubular side branch mounted into the fenestration and extending in both directions from the fenestration, sufficient length for sealing of an extension arm into the tubular side branch is provided without having the tubular side branch extending too far into the stent graft tubular body.
  • the internal portion of the tubular side branch extends toward the proximal end of the stent graft from the fenestration.
  • the tubular body has a tapered portion and the fenestration is in the tapered portion.
  • the aorta tapers as these major branch vessels extend from the aorta and tapering of the stent graft assists with maintaining a good blood flow and pressure in the stent graft.
  • the tubular side branch is mounted into the fenestration by being stitched to the tubular body around the periphery of the fenestration.
  • the stitching by which the tubular side branch is mounted and sealed into the fenestration extends circumferentially and diagonally from one end of the tubular side branch to the other such that the tubular side branch extends from the tubular body at an angle thereto.
  • the fenestration may be in the tapered portion of the tubular body and wherein the stitching by which the tubular side branch is mounted into the fenestration extends circumferentially and diagonally from one end of the tubular side branch to the other the angle between the tubular side branch and the wall of the tubular body in that region may be such that the tubular side branch extends substantially parallel to the tubular body as a whole.
  • the tubular side branch comprises a resilient ring around at least one and preferably both ends thereof.
  • the resilient ring is flexible so that it can be collapsed along with a stent graft when it is compressed and retailed in a deployment device but when released opens to a substantially circular form and provides a relatively rigid structure against which a self expanding or balloon expandable stent can be expanded when placing a extension arm into the tubular side branch.
  • the resilient ring or rings may have a diameter which is 10% to 15% less than that of the tubular side branch. For instance when the tubular side branch has a diameter of 8 mm the resilient ring may have a diameter of 7 mm.
  • the or each ring may be formed from at least two turns and preferably three turns of a shape memory wire such as NitinolTM wire and the ends of the NitinolTM wire may terminate in loops.
  • the use of the loops prevent sharp ends from the NitinolTM wire from digging into the vasculature into which the stent graft is deployed.
  • the rings are stitched to the tube by stitching.
  • the rings can alternatively be formed from stainless steel wire, plastics material or other suitable material. Stitching of the loops on the rings to the biocompatible graft material also prevents the resilient rings from being expanded by the pressure of a self expanding or balloon expandable stent placed therein and expanded.
  • the resilient stent may be formed from NitinolTM wire or stainless steel.
  • the stent can comprise at least one helical strut, a longitudinal strut or a zig-zag stent.
  • the resilient stent defines a cylindrical form having a diameter less than that of the tubular side branch to define a self contracting stent and hence when sewn onto the outside of the tube using stitching it provides a diameter reducing effect on the tubular side branch.
  • tubular side branch may be radiopaque markers adjacent each of the ends of the tubular side branch. These markers enable the physician to visualise the tubular side branch during an operation to assist with correct placement of a leg extension into the tubular side branch.
  • tubular side branch may extend beyond the fenestration externally of the tubular body.
  • Such an extension may have one or more stents thereon to maintain patency.
  • a stent graft comprising a tubular body of a biocompatible material, at least one fenestration in the tubular body and a tubular side branch sealingly received in the fenestration such that a portion of the tubular side branch extends within the tubular body and a portion of the tubular side branch extends exteriorly of the tubular body, the portion of the tubular side branch extending within the tubular body comprising a circumferential end having a substantially linear portion and the linear portion being engaged against an inner wall of the tubular body.
  • tubular side branch mounted into the fenestration and extending in both directions from the fenestration, sufficient length for sealing of an extension arm into the tubular side branch is provided without having the tubular side branch extending too far into the stent graft tubular body.
  • the linear portion of the inner circumferential end engaging against the wall provides a low profile for the inner end within the tubular body. This also assists with enabling a physician to extend a guide wire into the side arm because a guide wire being directed down along the inner wall of the tubular body will more easily enter the side branch where the circumference extends around and along the wall for some distance.
  • the resilient rings and the stent formed between the rings may be a single portion of material.
  • Such a combined stent and rings may comprise a portion of wire forming a first ring, a second ring, the second ring defining a plane which is substantially parallel to and spaced axially apart from the plane of the first ring and a plurality of helical wire portions extending between the first and second ring.
  • the wire is a shape memory wire such as NitinolTM wire.
  • the helical portions extend in both clockwise and anticlockwise directions between the rings at each end.
  • each ring is be formed from but not limited to two turns of a shape memory wire such as NitinolTM wire and the ends of the NitinolTM wire may terminate in loops.
  • a shape memory wire such as NitinolTM wire and the ends of the NitinolTM wire may terminate in loops.
  • Part of each ring at each end can be formed by circumferential portions extending from each helical portion.
  • a stent graft comprising a tubular body of a biocompatible material, at least one fenestration in the tubular body and a tubular side branch sealingly received in the fenestration such a that an inner portion of the tubular side branch extends within the tubular body and an outer portion of the tubular side branch extends exteriorly of the tubular body, the tubular side branch comprises a reinforcement stent and wherein the reinforcement stent comprises a portion of wire forming a first ring, a second ring, the second ring defining a plane which is substantially parallel to and spaced axially apart from the plane of the first ring and a plurality of helical wire portions extending between the first and second ring and wherein the inner portion comprises a circumferential end having a substantially linear portion and the linear portion being engaged against an inner wall of the tubular body.
  • stent graft 10 has a tubular body 12 which includes a tapered central region 14 and a lower parallel sided portion 15.
  • the tubular body is supported by stents 16.
  • stents 16 are self expanding Gianturco zig zag Z stents but other forms of stents may also be included.
  • tubular side branches 22 and 24 Mounted into each of the fenestrations 18 and 20 are tubular side branches 22 and 24 respectively.
  • the tubular side branches 22 and 24 each have an inner portion 27 which extends within the tubular body of the stent graft and an outer portion 29 which extends outside of the tubular body of the stent graft.
  • the tubular side branches are depicted as being longitudinally aligned with each other but their circumferential and longitudinal position may vary depending upon the configuration of side arteries in the vessel into which the stent graft is to be deployed. It will be noted that in this embodiment both the tubular side branch 22 and the tubular side branch 24 have their external portions facing distally.
  • Each of the tubular side branches 22 and 24 are stitched into the periphery of the fenestration by stitching 30 and 30a respectively.
  • the stitching extends circumferentially and diagonally from one end of the tubular side branch to the other.
  • the angled stitching 30 in fact means that the tubular side branch 22 extends substantially parallel to the tubular body 12.
  • tubular side branch 24 mounted into the fenestration 20 with diagonal stitching 30a is in a substantially straight sided portion of the tubular body 12 and therefore the tubular side branch extends out at a angle to the tubular body 20.
  • FIG. 3 shows a side view of a tubular side branch according to one embodiment of the invention before it is stitched into the fenestration in a main stent graft.
  • Figure 4 shows a cross-section of embodiment shown in Figure 3 along the line 4 - 4' in Figure 3 .
  • the tubular side branch 40 comprises a tubular body 41 of a biocompatible graft material. At each end of the tubular body 41, a resilient ring 43 is stitched onto the biocompatible material.
  • the resilient ring is preferably formed of two and preferably three turns of NitinolTM wire, the ends of which terminate in loops 45a which are stitched by stitching 46a to the biocompatible graft material body 41.
  • a stent 44 formed from a resilient material.
  • the resilient stent may be formed from NitinolTM wire or stainless steel.
  • the stent 44 is stitched onto the tubular body 41 with stitching 47.
  • Radiopaque markers 48 are provided at each end of the tubular side branch so that a physician can visualise the position of the tubular side branch when operating within a patient.
  • the dotted line 49 shows the approximate line of stitching by which the tubular side branch 40 is mounted into the fenestrations as discussed in relation to Figures 1 and 2 . It will be noted that the line of stitching extends circumferentially and diagonally from one side at one end to the other side at the other end.
  • Figures 5 and 6 show an alternative embodiment of a stent graft incorporating a tubular side branch according to the present invention.
  • the stent graft 50 has a tubular body 52 of a graft material and a tubular side branch 54 stitched into a tapered portion 56 of the tubular body 52.
  • the tubular side branch 54 is received in a fenestration by stitching 60.
  • the tubular side branch 54 extends exteriorly of the stent graft with a tubular extension 62 terminating in a resilient ring 64. It will be noted that in this embodiment the tubular side branch 54 has its external portion facing distally.
  • Figure 7 shows an alternative embodiment of a stent graft according to the present invention.
  • Figure 7 uses the same reference numerals as Figure 1 for corresponding items.
  • the stent graft 10 has a tubular body 12 which includes a tapered central region 14 and a lower parallel sided portion 15.
  • the tubular body is supported by stents 16.
  • stents 16 Preferably these stents are self expanding Gianturco zig zag Z stents but other forms of stents may also be included.
  • tubular side branches 22 and 24 Mounted into each of the fenestrations 18 and 20 are tubular side branches 22 and 24 respectively.
  • the tubular side branches 22 and 24 each have an inner portion 27 which extends within the tubular body of the stent graft and an outer portion 29 which extends outside of the tubular body of the stent graft.
  • Each of the tubular side branches 22 and 24 are stitched into the periphery of the fenestration by stitching 30 and 30a respectively.
  • the stitching extends circumferentially and diagonally from one end of the tubular side branch to the other.
  • the angled stitching 30 in fact means that the tubular side branch 22 extends substantially parallel to the tubular body 12.
  • the tubular side branch 24 mounted into the fenestration 20 with diagonal stitching 30a is in a substantially straight sided portion of the tubular body 12 and therefore the tubular side branch extends out at an angle to the tubular body 20.
  • tubular side branch 22 has its external portion facing distally and the tubular side branch 24 has its external portion facing proximally.
  • Figure 8 shows a side view of a tubular side branch according to one embodiment of the invention before it is stitched into the fenestration in a main stent graft.
  • Figure 9 shows a cross-section of embodiment shown in Figure 8 along the line 9 - 9' in Figure 8 .
  • the tubular side branch 40 comprises a tubular body 41 of a biocompatible graft material. Surrounding and supporting the tubular body 41 is a stent 43a.
  • the stent 43a comprises an integral assembly of a first ring 45, a second ring 47, the second ring 47 defining a plane which is substantially parallel to and spaced axially apart from the plane of the first ring45, and helical wires 49 extending between the first and second rings.
  • the stent 43a is shown in more detail in Figure 10A .
  • the stent may be formed from NitinolTM wire or stainless steel.
  • the stent 43a is stitched onto the tubular body 41 with stitching 60.
  • the tubular body is shaped at one end by the ring 45 having a linear portion on one side, as shown in more detail in Figure 10B , such that the tubular body curves in at 50.
  • Radiopaque marker 48 is provided at the outer end of the tubular side branch so that a physician can visualise the position of the tubular side branch on the stent graft when operating within a patient. Radiopaque markers 48a can also be provided at the inner end of the tubular side branch so that a physician can visualise the position of the tubular side branch within the stent graft when catheterising it when operating within a patient
  • the dotted line 52 shows the approximate line of stitching by which the tubular side branch 40 is mounted into the fenestrations as discussed in relation to Figures 1 and 2 . It will be noted that the line of stitching extends circumferentially and diagonally from one side at one end to the other side at the other end.
  • FIGs 10A, 10B and 10C show one embodiment of construction for the stent 43 as shown in Figure 8 .
  • the stent comprises Nitinol wire of a diameter of 0.006in formed into a first ring 45 of least two turns of wire, A second ring 47 formed from at least two turns of wire and helical arms 49 between them.
  • the entire stent is formed from a single length of wire starting at loop 57 and terminating at loop 59.
  • the upper ring 45 has a circumferential shape as shown in Figure 10B .
  • the circumference of the ring 45 includes a linear portion 46.
  • This linear portion 46 when the stent is installed on a side arm and the side arm is fitted into a stent graft, engages against the wall of the stent graft as shown in Figure 11 .
  • Figure 10C shows the shape of the rings 47 at the end of the tubular side branch which in use is intended to be outside the stent graft in use.
  • Figure 11 shows a view into the stent graft shown in Figure 7 in the direction shown by the arrow 11 in Figure 7 .
  • the side arm 22 has its linear portion 46 engaged against the inner wall 58 of the tubular body 12.
  • the side arm 24 is mounted into the lower parallel sided portion 15.
  • Figures 12A,12B and 12C show views of combined rings and longitudinal strut forming a stent 60 used on the side arm according to an alternative embodiment of the present invention.
  • the stent 60 comprises upper and lower rings 62 and 64 joined by a single longitudinal strut 66.
  • the stent is formed from a single piece of Nitinol or similar wire and the wire terminates in respective loops 68 and 69.
  • Figure 12B shows the ring 64 with loop 69 and a flattened portion 65 which fits against the inner wall of the stent graft as discussed earlier.
  • Figure 12C shows the ring 62 with the loop 68.
  • FIG 13 shows a detailed view of a tubular side branch using the stent shown in Figure 12 .
  • the tubular side branch 70 comprises a tubular portion of biocompatible graft material 72 with the stent 60 outside of it so that the ring 62 is at one end of the tubular body and the ring 64 is at the other end of the tubular body and the strut 66 extends along the outside of the tubular body.
  • the rings 62 and 64 are stitched to the tubular body by stitching 74 and the strut 66 is stitched to the tubular body by stitching 76.
  • Figure 14 shows a portion of a stent graft utilising the tubular side branch shown in Figure 13 .
  • the stent graft 80 has a fenestration 82 into which the tubular side branch 70 is sewn.
  • One of the stents 84 of the stent graft 80 passes over the tubular side branch 70.
  • Radiopaque markers 86 are provided on the terminal end of the tubular side branch 70.

Claims (17)

  1. Stent-Graftprothese (10, 50, 80) mit einem röhrenförmigen Körper (12, 41, 52) aus einem biokompatiblen Material, zumindest einem Fenster (18, 20, 58, 82) im röhrenförmigen Körper und einem röhrenförmigen Seitenast (22, 24, 40, 54, 70), der dichtend in dem zumindest einen Fenster aufgenommen ist, so dass sich ein Innenabschnitt (27) des röhrenförmigen Seitenastes im röhrenförmigen Körper erstreckt und sich ein Außenabschnitt (29) des röhrenförmigen Seitenastes außerhalb des röhrenförmigen Körpers erstreckt, dadurch gekennzeichnet, dass der Innenabschnitt des röhrenförmigen Seitenastes ein Umfangsende mit einem linearen Abschnitt (46) umfasst, wobei der lineare Abschnitt in eine Innenwand (58) des röhrenförmigen Körpers in Eingriff steht.
  2. Stent-Graftprothese nach Anspruch 1, worin der Innenabschnitt (27) des röhrenförmigen Seitenastes (22, 24, 40, 54, 70) einen nachgiebigen Ring (43, 45, 62) um ihn herum umfasst, wobei der nachgiebige Ring den Abschnitt (46) zum Eingriff gegen eine Innenwand (58) des röhrenförmigen Körpers umfasst.
  3. Stent-Graftprothese nach Anspruch 1 oder 2, die einen nachgiebigen Ring (43, 47, 64) um den Außenabschnitt (29) des röhrenförmigen Seitenastes (22, 24, 40, 54, 70) umfasst.
  4. Stent-Graftprothese nach Anspruch 2 oder 3, worin der oder jede nachgiebige Ring aus ein bis drei Windungen eines Formgedächtnisdrahtes geformt ist und die Enden des Drahtes in Schlaufen (45a) enden.
  5. Stent-Graftprothese nach Anspruch 2, 3 oder 4, worin der oder jeder Ring aus Edelstahldraht, Plastikmaterial oder einem anderen geeigneten Material geformt ist.
  6. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin sich der Innenabschnitt (27) des röhrenförmigen Seitenastes (22, 24, 49, 54, 70) zum proximalen ende der Stent-Graftprothese vom Fenster (18, 29) aus erstreckt.
  7. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin der röhrenförmige Körper einen verjüngten Abschnitt (14, 56) aufweist und sich das Fenster (18, 58) in dem verjüngten Abschnitt befindet.
  8. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin der röhrenförmige Seitenast (22, 24) durch Annähen (30, 30a, 60) am röhrenförmigen Körper um den Umfang des Fensters im Fenster (18, 20, 58, 82) befestigt ist.
  9. Stent-Graftprothese nach Anspruch 8, worin sich die Naht (30) um den Umfang und diagonal von einem Ende des röhrenförmigen Seitenastes (22) zum anderen Ende erstreckt, so dass sich der röhrenförmige Seitenast vom röhrenförmigen Körper (12) in einem Winkel dazu erstreckt.
  10. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, die einen Stent (43, 44, 60, 84), der aus einem nachgiebigen Material auf dem röhrenförmigen Seitenast geformt ist, umfasst.
  11. Stent-Graftprothese nach Anspruch 10, worin der Stent (44) aus einer Gruppe ausgewählt ist, die zumindest eine spiralförmige Strebe (49, 53), eine Längsstrebe (66) oder einen Zickzack-Stent (44) umfasst.
  12. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin der röhrenförmige Seitenast röntgenopake Markierungen (48) auf dem anderen Abschnitt des röhrenförmigen Seitenastes umfasst.
  13. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin sich der röhrenförmige Seitenast über das Fenster (18, 20, 58, 82) hinaus außerhalb des röhrenförmigen Körpers erstreckt.
  14. Stent-Graftprothese nach einem der vorhergehenden Ansprüche, worin der röhrenförmige Seitenast einen Verstärkungsstent (43a) umfasst.
  15. Stent-Graftprothese nach Anspruch 14, worin der Verstärkungsstent (43a) einen Drahtabschnitt umfasst, der einen ersten Ring (45) formt, einen zweiten Ring (47), wobei der zweite Ring eine Ebene definiert, die im Wesentlichen parallel zur Ebene des ersten Rings ist und axial davon beabstandet ist, und eine Vielzahl von spiralförmigen Drahtabschnitten (49, 53, 55), umfasst, die sich zwischen dem ersten und dem zweiten Ring erstrecken.
  16. Stent-Graftprothese nach Anspruch 15, worin sich die spiralförmigen Drahtabschnitt (49, 53, 55) sowohl im Uhrzeigersinn als auch gegen den Uhrzeigersinn zwischen den Ringen (45, 47) an jedem Ende erstrecken.
  17. Stent-Graftprothese (10, 50, 80) nach Anspruch 2, worin der nachgiebige Ring (45) Teil eines Verstärkungsstents (43a) bildet und worin der Verstärkungsstent ferner einen zweiten Ring (47), wobei der zweite Ring eine Ebene definiert, die im Wesentlichen parallel zur Ebene des ersten Rings ist und axial davon beabstandet ist, und eine Vielzahl von spiralförmigen Drahtabschnitten (49, 53, 55), umfasst, die sich zwischen dem ersten und dem zweiten Ring erstrecken.
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US20070219621A1 (en) 2007-09-20
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US8574288B2 (en) 2013-11-05
US20110172762A1 (en) 2011-07-14
US7914572B2 (en) 2011-03-29

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